The present invention generally relates to surgical methods, and more specifically relates to breast augmentation, reconstruction and breast implant revision surgical methods.
Prostheses or implants for augmentation and/or reconstruction of the human body are well known. Capsular contracture is a complication associated with surgical implantation of prostheses, particularly with soft implants, and even more particularly, though certainly not exclusively, with fluid-filled breast implants.
When a foreign material is implanted in a human body, the immune system attempts to isolate the material by forming a collagen-based capsule. After time, the capsule may contract, becoming hardened and painful, and possibly requiring surgical correction. This phenomenon is known as “capsular contracture” and is a significant adverse event for breast implant patients.
Capsular contracture is believed to be a result of the immune system response to the presence of a foreign material in the body. A normal response of the body to the presence of a newly implanted object, for example a breast implant, is to form a capsule of tissue, primarily collagen fibers, around the implant. Capsular contracture occurs when the capsule begins to contract and squeeze the implant. This contracture can be discomforting or even extremely painful, and can cause distortion of the augmented or reconstructed breast. The exact cause of contracture is not known. However, some factors may include bacterial contamination of the implant prior to or after placement, submuscular versus subgladular placement, and smooth surface implants versus textured surface implants, and bleeding, pocket size or trauma to the area. It is also known that contracture rates are increased in patients following an implant replacement after removal for an initial contracture as well as in patients undergoing breast reconstruction following mastectomy or radiation therapy for breast cancer.
A conventional procedure for treating a contracted capsule is known as a capsulectomy, in which capsular tissue is removed from the breast either with the implant or following removal of the implant. This is generally performed once contracture has reached a severity which considerably affects the look and feel of the breast or causes significant discomfort to the patient. The procedure involves gaining entry to the breast interior by way of a surgical incision and removing the implant and the entire capsule of fibrous tissue surrounding the implant. Most commonly, this capsule is removed whole, to eliminate the chance of a recurrence. Capsule removal is an invasive procedure which involves removal of healthy tissue from the already compromised breast, as it is a goal to remove all of fibrous capsule tissue. Most often, because of the significant loss of tissue, a new implant must be introduced into the breast cavity. When a patient has thin tissue and not sufficient breast tissue and/or breast glandular tissue, removing the capsular tissue can result in severe deficiency of remaining breast tissue, which may lead to severe rippling, visibility and possibly even skin necrosis due to poor blood supply, when the new implant is placed. In some cases the capsule is not entirely removed following explanation of the implant, but is surgically scored to release the tension of the contracted capsule.
There is still a need for better methods for reducing the occurrence or reoccurrence of capsular contracture in patients receiving breast implants.